Imaging biomarker roadmap for cancer studies

被引:780
作者
O'Connor, James P. B. [1 ]
Aboagye, Eric O. [2 ]
Adams, Judith E. [3 ]
Aerts, Hugo J. W. L. [4 ]
Barrington, Sally F. [5 ]
Beer, Ambros J. [6 ]
Boellaard, Ronald [7 ]
Bohndiek, Sarah E. [8 ]
Brady, Michael [9 ]
Brown, Gina [10 ]
Buckley, David L. [11 ]
Chenevert, Thomas L. [12 ]
Clarke, Laurence P. [13 ]
Collette, Sandra [14 ]
Cook, Gary J. [5 ]
Desouza, Nandita M. [15 ]
Dickson, John C. [16 ]
Dive, Caroline [17 ]
Evelhoch, Jeffrey L. [18 ]
Faivre-Finn, Corinne [19 ]
Gallagher, Ferdia A. [8 ]
Gilbert, Fiona J. [8 ]
Gillies, Robert J. [20 ]
Goh, Vicky [5 ]
Griffiths, John R. [8 ]
Groves, Ashley M. [16 ]
Halligan, Steve [16 ]
Harris, Adrian L. [9 ]
Hawkes, David J. [16 ]
Hoekstra, Otto S. [21 ]
Huang, Erich P. [22 ]
Hutton, Brian F. [16 ]
Jackson, Edward F. [23 ]
Jayson, Gordon C. [24 ]
Jones, Andrew [25 ]
Koh, Dow-Mu [15 ]
Lacombe, Denis [26 ]
Lambin, Philippe [27 ]
Lassau, Nathalie [28 ]
Leach, Martin O. [15 ]
Lee, Ting-Yim [29 ]
Leen, Edward L. [2 ]
Lewis, Jason S. [30 ]
Liu, Yan [26 ]
Lythgoe, Mark F. [31 ]
Manoharan, Prakash [1 ]
Maxwell, Ross J. [32 ]
Miles, Kenneth A. [16 ]
Morgan, Bruno [33 ]
Morris, Steve [34 ]
机构
[1] Univ Manchester, CRUK & EPSRC Canc Imaging Ctr Cambridge & Manches, Manchester, Lancs, England
[2] Imperial Coll, Dept Surg & Canc, London, England
[3] Cent Manchester Univ Hosp NHS Fdn Trust, Dept Clin Radiol, Manchester, Lancs, England
[4] Harvard Med Sch, Dept Radiat Oncol, Boston, MA USA
[5] Kings Coll London, CRUK & EPSRC Comprehens Imaging Ctr KCL & UCL, London, England
[6] Univ Hosp Ulm, Dept Nucl Med, Ulm, Germany
[7] Univ Groningen, Univ Med Ctr Groningen, Dept Nucl Med & Mol Imaging, Groningen, Netherlands
[8] Univ Cambridge, CRUK & EPSRC Canc Imaging Ctr Cambridge & Manches, Cambridge, England
[9] Univ Oxford, CRUK & EPSRC Canc Imaging Ctr, Oxford, England
[10] Royal Marsden Hosp, Dept Radiol, London, England
[11] Univ Leeds, Div Biomed Imaging, Leeds, W Yorkshire, England
[12] Univ Michigan, Dept Radiol, Ann Arbor, MI 48109 USA
[13] NCI, Canc Imaging Program, Bethesda, MD 20892 USA
[14] EORTC, Biostat, Brussels, Belgium
[15] Inst Canc Res, CRUK Canc Imaging Ctr, London, England
[16] UCL, CRUK & EPSRC Canc Imaging Ctr KCL & UCL, London, England
[17] CRUK Manchester Inst, Clin & Expt Pharmacol, Manchester, Lancs, England
[18] Merck & Co Inc, Translat Biomarkers, West Point, PA USA
[19] Univ Manchester, Radiotherapy Related Res Grp, Manchester, Lancs, England
[20] H Lee Moffitt Canc Ctr & Res Inst, Canc Imaging & Metab, Tampa, FL USA
[21] Vrije Univ Amsterdam, Med Ctr, Dept Radiol & Nucl Med, Amsterdam, Netherlands
[22] NCI, Biometr Res Program, Bethesda, MD 20892 USA
[23] Univ Wisconsin, Dept Med Phys, 1530 Med Sci Ctr, Madison, WI 53706 USA
[24] Univ Manchester, Inst Canc Sci, Manchester, Lancs, England
[25] Christie Hosp NHS Fdn Trust, Med Phys, Manchester, Lancs, England
[26] EORTC, EORTC Headquarters, Brussels, Belgium
[27] Maastricht Univ, Dept Radiat Oncol, Maastricht, Netherlands
[28] Gustave Roussy Canc Campus, Dept Imaging, Villejuif, France
[29] Robarts Res Inst, Imaging Res Labs, London, ON, Canada
[30] Mem Sloan Kettering Canc Ctr, Dept Radiol, 1275 York Ave, New York, NY 10021 USA
[31] UCL, Ctr Adv Biomed Imaging, London, England
[32] Newcastle Univ, Northern Inst Canc Res, Newcastle Upon Tyne, Tyne & Wear, England
[33] Univ Leicester, Canc Studies & Mol Med, Leicester, Leics, England
[34] UCL, Inst Epidemiol & Hlth, London, England
[35] Mt Vernon Hosp, Paul Strickland Scanner Ctr, London, England
[36] Johns Hopkins Univ, Sch Med, Dept Radiol, Baltimore, MD 21205 USA
[37] Univ Birmingham, Inst Canc & Genom, Birmingham, W Midlands, England
[38] Inst Canc Res, Breakthrough Breast Canc Res Ctr, London, England
[39] Univ Antwerp, Mol Imaging Ctr Antwerp, Antwerp, Belgium
[40] Duke Univ, Sch Med, Dept Radiol, Durham, NC USA
[41] Univ Sussex, Brighton & Sussex Med Sch, Brighton, E Sussex, England
[42] Univ Sheffield, Dept Oncol & Metab, Sheffield, S Yorkshire, England
[43] MRC Biostat Unit, Cambridge, England
[44] Inst Canc Res, CRUK Canc Therapeut Unit, London, England
[45] Univ Texas Austin, Inst Computat Engn & Sci, Austin, TX 78712 USA
基金
英国工程与自然科学研究理事会;
关键词
CONTRAST-ENHANCED MRI; POSITRON-EMISSION-TOMOGRAPHY; GROUP DEVELOPMENTAL PATHWAY; SURROGATE END-POINTS; HIGH FAMILIAL RISK; CLINICAL-TRIALS; BREAST-CANCER; PHASE-I; COST-EFFECTIVENESS; PROGNOSTIC-SIGNIFICANCE;
D O I
10.1038/nrclinonc.2016.162
中图分类号
R73 [肿瘤学];
学科分类号
100214 ;
摘要
Imaging biomarkers (IBs) are integral to the routine management of patients with cancer. IBs used daily in oncology include clinical TNM stage, objective response and left ventricular ejection fraction. Other CT, MRI, PET and ultrasonography biomarkers are used extensively in cancer research and drug development. New IBs need to be established either as useful tools for testing research hypotheses in clinical trials and research studies, or as clinical decision-making tools for use in healthcare, by crossing 'translational gaps' through validation and qualification. Important differences exist between IBs and biospecimen-derived biomarkers and, therefore, the development of IBs requires a tailored 'roadmap'. Recognizing this need, Cancer Research UK (CRUK) and the European Organisation for Research and Treatment of Cancer (EORTC) assembled experts to review, debate and summarize the challenges of IB validation and qualification. This consensus group has produced 14 key recommendations for accelerating the clinical translation of IBs, which highlight the role of parallel (rather than sequential) tracks of technical (assay) validation, biological/clinical validation and assessment of cost-effectiveness; the need for IB standardization and accreditation systems; the need to continually revisit IB precision; an alternative framework for biological/clinical validation of IBs; and the essential requirements for multicentre studies to qualify IBs for clinical use.
引用
收藏
页码:169 / 186
页数:18
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